Consulting Wallah › Device Explorer › Dental › Hand-held intraoral dental x-ray system, digital
Device Explorer · FDA GUDID · GMDN 44606

Hand-held intraoral dental x-ray system, digital

A diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interven

US‑registered devices66in commercial distribution
Companies20labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Vatech Co., Ltd.2335%
Nanoray Co.,Ltd69%
Digimed Co., Ltd.69%
Dexcowin Co., Ltd.58%
Denterprise International, Inc.46%
Guangzhou Ajax Medical Equipment Co., Ltd.35%
Remedi Co.,Ltd.35%
Alliage S/A Indústrias Médico Odontológica35%

Top labelers

CompanyDevicesShare
Vatech Co., Ltd.2335%
Nanoray Co.,Ltd69%
Digimed Co., Ltd.69%
Dexcowin Co., Ltd.58%
Denterprise International, Inc.46%
Guangzhou Ajax Medical Equipment Co., Ltd.35%
Remedi Co.,Ltd.35%
Alliage S/A Indústrias Médico Odontológica35%
Ecotron23%
Shenzhen Xpectvision Technology Co.,Ltd.12%
Changzhou Sifary Medical Technology Co., Ltd.12%
Rolence Enterprise Inc.12%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

XpectVisionADSEighteethRolenceSmil-O-RayMOBILE-XXray2Go MiniXray2GoFlight Dental SystemsAcuity DX+WeRayCLAROXPortable Dental X-ray (R2 Port-X with Back scattPortable Dental X-ray (R2 Port-X without Back scPortable Dental X-ray (NR-F350 with Back scatterPortable Dental X-ray (CS 2300P)

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EHDUnit, X-Ray, Extraoral With Timer61
MUHSystem, X-Ray, Extraoral Source, Digital4
MUHSystem,X-Ray,Extraoral Source,Digital4
IZLSystem, X-Ray, Mobile1

GMDN & GCC registration

  • GMDN code 44606 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 77% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Kilogram) · 3Height (Millimeter) · 3Width (Millimeter) · 3Length (Millimeter) · 2Depth (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many hand-held intraoral dental x-ray system, digital products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hand-held intraoral dental x-ray system, digital", from 20 companies. The largest labeler is Vatech Co., Ltd. with 35% of records.

Which FDA product codes apply?

EHD (Unit, X-Ray, Extraoral With Timer), MUH (System, X-Ray, Extraoral Source, Digital), MUH (System,X-Ray,Extraoral Source,Digital), IZL (System, X-Ray, Mobile)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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